acute otitis media in general practice, antibiotics, placebo, infants acute middenoorontsteking in huisartsenpraktijk, antibiotica en placebo, kinderen onder de 2 jaar.
Conditions
Interventions
Amoxicillin suspension 40mg/kg/day in three divide doses for 10 days or placebo suspension.
Sponsors
Julius Center for Health Sciences and Primary Care, UMC Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged 6 months to two years with acute otitis media in general practice
Exclusion criteria
Exclusion criteria: 1. Antibiotic treatment in de preceding 4 weeks 2. Allergy to amoxicillin 3. Compromised immunity 4. Craniofacial abnormalities 5. Down's syndrome 6. Being entered in this study before.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Persistent symptoms at day 4, assessed by the doctor and defined as persistent earache, fever, crying or being irritable | — |
Secondary
| Measure | Time frame |
|---|---|
| - Clinical treatment failure at day 11 - Duration of fever or/of pain/crying - The mean number of doses of analgesics given - The percentage of children with middle ear effusion at 6 weeks, 3 months and 6 months - Adverse effects | — |
Contacts
Public ContactR.A.M.J. Damoiseaux
Outcome results
None listed